Canadian clinical trial registry

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Study Description

 This study is eligible for STEP-1 funding. Find more information here. 

This is an early-phase clinical trial testing a new kind of treatment called CLIC-2201. It uses a patient’s own immune cells, which are specially modified to better recognize and fight certain types of cancer that affect B cells. This treatment is being offered to patients whose cancer has come back or has not responded to other treatments.

Inclusion Criteria

Cohort A (B cell lymphoma):

• Must be 18 years of age or older of age at time of consent
• You have B cell lymphoma that has come back or hasn’t gotten better with other treatments
• You’ve already tried at least two treatments, or had a stem cell transplant, or CAR-T therapy before
• You meet the necessary organ function and bloodwork requirements 
• You must be up and about at least half of your waking hours 
• If you could become pregnant or get someone pregnant, you agree to use birth control for a year after the treatment

Cohort B (B-ALL):

• Must be between 1 and 21 years old, and you (and/or your parent or guardian) agree to join the study
• You have B-cell acute lymphoblastic leukemia (B-ALL) that has come back or hasn’t gotten better with other treatments.
• You’ve already tried at least two treatments, or had a stem cell transplant, or CAR-T therapy before
• If you had a treatment that targeted CD22, your cancer must still show signs of that marker
• You meet the necessary organ function and bloodwork requirements 
• You must be up and about at least half of your waking hours 
• If you could become pregnant or get someone pregnant, you agree to use birth control for a year after the treatment
• You are okay with a bone marrow biopsy before starting the study

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team. 

Publications

Both Cohorts A and B

• Any uncontrolled or serious active infection at the time of enrolment.
• Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.
• Live vaccine ≤6 weeks prior to enrolment
• Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.
• Treatment with any of the following in the specified time period before leukapheresis:
  • Allogeneic HCT within 3 months,
  • Autologous HCT within 3 months,
  • CD19 CAR-T cell infusion within 3 months,
  • Donor lymphocyte infusion (DLI) within 3 months,
  • Bendamustine within the last 6 months,
  • Any investigational agent within 30 days or 5 half-lives (whichever is shorter),
  • Systemic administration of therapeutic dose corticosteroids (>20 mg/day prednisone or equivalent for adults and ≥ 12 mg/m2/day for paediatric participants) within 7 days prior to leukapheresis.
  • Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks.
  • Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.
• Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.
• Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.
• Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.
• Any Human Immunodeficiency Virus (HIV) infection at time of screening.
• Hypersensitivity to fludarabine or cyclophosphamide.
• Any allergy to gentamycin or its derivatives
• Pregnant or nursing participants.